ADVIL NUIT Capsule
Country: Kanada
Tungumál: franska
Heimild: Health Canada
Vara einkenni
(SPC)
17-10-2019
Sum skjöl fyrir þessa vöru eru ekki tiltæk eins og er, þú getur sent beiðni til þjónustu við viðskiptavini okkar og við munum láta þig vita um leið og við getum fengið þau.
Senda beiðni.
Senda beiðni.
Virkt innihaldsefni:
Ibuprofène; Chlorhydrate de diphénhydramine
Fáanlegur frá:
GLAXOSMITHKLINE CONSUMER HEALTHCARE ULC
ATC númer:
M01AE51
INN (Alþjóðlegt nafn):
IBUPROFEN, COMBINATIONS
Skammtar:
200MG; 25MG
Lyfjaform:
Capsule
Samsetning:
Ibuprofène 200MG; Chlorhydrate de diphénhydramine 25MG
Stjórnsýsluleið:
Orale
Einingar í pakka:
10/20/40
Gerð lyfseðils:
En vente libre
Lækningarsvæði:
OTHER NONSTEROIDAL ANTIIMFLAMMATORY AGENTS
Vörulýsing:
Numéro de groupe d'ingrédients actifs (GIA) :0252788001; AHFS:
Leyfisstaða:
APPROUVÉ
Leyfisdagur:
2020-05-13
Vara einkenni
_ _
_Pfizer Consumer Healthcare, a division of Pfizer Canada ULC _
_Page 1 of 46_
PRODUCT MONOGRAPH
_ _
ADVIL NIGHTTIME
Ibuprofen 200 mg and Diphenhydramine Hydrochloride 25 mg Capsules
Analgesic/Sleep Aid
Pfizer Consumer Healthcare, a divison of Pfizer Canada ULC
450-55 Standish Court
Mississauga, Ontario
L5R 4B2
Date of Preparation:
October 17, 2019
Submission Control No: 231333
_ _
_Pfizer Consumer Healthcare, a division of Pfizer Canada ULC _
_Page 2 of 46_
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
.........................................................3
SUMMARY PRODUCT INFORMATION
........................................................................3
INDICATIONS AND CLINICAL USE
..............................................................................3
CONTRAINDICATIONS
...................................................................................................4
ADVERSE REACTIONS
..................................................................................................13
DOSAGE AND ADMINISTRATION
..............................................................................24
OVERDOSAGE
................................................................................................................24
ACTION AND CLINICAL PHARMACOLOGY
............................................................26
STORAGE AND STABILITY
..........................................................................................29
SPECIAL HANDLING INSTRUCTIONS
.......................................................................29
DOSAGE FORMS, COMPOSITION AND PACKAGING
.............................................29
PART II: SCIENTIFIC INFORMATION ...................................................................30
PHARMACEUTICAL INFORMATION
..........................................................................30
CLINICAL TRIALS
..........................................................................................................32
DETAILED PHARMACOLOGY
...........................
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